Amgen, Pfizer, and Teva Lead Drug Approvals
A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Amgen, Pfizer, and Teva.
Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday November 2, 2016 date to Tuesday November 8, 2016.
FDA OKs Expanded Use of Amgen’s Enbrel
Amgen has received approval from the US Food and Drug Administration (FDA) for its supplemental biologics license application for the expanded use of Enbrel (etanercept), its anti-inflammatory biologic which is now indicated to treat pediatric patients (ages 4-17) with chronic moderate-to-severe plaque psoriasis.
Enbrel is a soluble form of a tumor necrosis factor receptor that was approved by the FDA in 1998 for moderate-to-severe rheumatoid arthritis. It was later approved in 1999 to treat moderate-to-severe polyarticular juvenile idiopathic arthritis, in 2002 to treat psoriatic arthritis, in 2003 to treat patients with ankylosing spondylitis, and in 2004 to treat moderate-to-severe plaque psoriasis in adults.
Pfizer Gets OK in China for Pneumococcal Vaccine
Pfizer has received approval from the Chinese Food and Drug Administration (CFDA) to market its pneumococcal 13-valent conjugate vaccine, Prevenar 13, in China for active immunization to prevent invasive diseases, including bacteremic pneumonia, meningitis, septicemia, and bacteremia caused by Streptococcus pneumoniae.
Prevenar 13 is a pneumococcal conjugate vaccine and is included in the pediatric National Immunization Programs of countries in the Asia Pacific region such as Australia, Hong Kong, Japan, and Taiwan.Prevenar 13 is designed to protect against Streptococcus pneumoniae serotypes included in the vaccine, and is not designed to protect against serotypes not present in the vaccine or other microorganisms that cause invasive disease, pneumonia, or otitis media. Prevnar 13 is the trade name of the vaccine in the US, Canada, and Taiwan.
Teva Gets FDA OK for Generic Antihypertensive Drugs
Teva Pharmaceutical Industries has received approval from the US Food and Drug Administration (FDA) for generic Tribenzor (olmesartan medoxomil, amlodipine, and hydrochlorothiazide) tablets for treating hypertension and is in the final stages of launch preparation. Teva also recently received approval and launched generic Azor (amlodipine and olmesartan medoxomil) tablets in the US for treating hypertension, alone, or with other antihypertensive agents.
Tribenzor by Daiichi Sankyo was approved by the FDA in July 2010 and had annual sales of approximately $240 million in the US, according to IMS data as of August 2016 and as cited by Teva.
Azor, also by Daiichi Sankyo, was approved by the FDA in September 2007 and had annual sales of approximately $354.1 million in the US as of August 2016, according to IMS data, and as cited by Teva.
Source: Teva Pharmaceutical Industries